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NCT Number: NCT07634952

Mitigation of Health Effects in Outdoor Workers by Reducing Exposure to Heat and Air Pollution

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in outdoor workers.

The main questions it aims to answer are:

* Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce physiological strain experienced by individuals working in hot environments, measured using the Heat Strain Score Index?

Researchers will compare measurements between outdoor workers carrying out their activities in the absence of intervention (control group), those carrying out their activities with behavioural recommendations (recommendation intervention group) and those carrying out their activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and physiological strain are different between intervention groups.

Participants will:

* Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Complete the Heat Strain Score Index questionnaire in three repeated assessments * Provide samples of urine, blood, saliva and hair for measurement of various biomarkers in three repeated assessments

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Key information

Conditions

Heat Strain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Thessaly, Trikala, Greece

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • Municipality outdoor workers
  • Regularly working outdoors for al least 6 hours per day
  • Living in León (Spain) or Trikala (Greece)
  • Clinically healthy
  • No history of diabetes mellitus type 2 (DM2)
  • No history of arterial hypertension

Exclusion criteria

  • Currently smoking
  • Presence of any smoking residents in the household
  • Not residing at the household for at least 5 days a week
  • Planning to move from the current home within the next two months
  • No access to Wi-Fi or 4G/5G mobile phone
  • Severe chronic conditions (congestive heart failure, ischemic heart disease, significant valvular heart disease, DM2, inflammatory diseases, renal failure, or active cancer)
  • Drugs abuse
  • Alcohol abuse
  • Psychiatric disorders
  • Severe mental disability that interferes with answering questions or following instructions

Treatment and study plan

Heat intervention

Other

The participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools to be developed by the project research team

Other names: Behavioral intervention to reduce exposure to heat

Heat and air pollution mitigation intervention

Other

The participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces.

Other names: Behavioral intervention to reduce exposure to heat and air-pollution

Primary outcomes

  1. Heat Strain Score Index

    Time frame: The HSSI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    The Heat Strain Score Index (HSSI) is a questionnaire-based assessment tool used to assess the risk of heat strain on individuals exposed to hot environments, using a questionnaire. It integrates multiple factors, such as environmental conditions, work intensity, clothing, and physiological responses, to estimate the likelihood of heat stress affecting a person.

Secondary outcomes

  1. Daily heart rate

    Time frame: Daily measurements - for the whole duration of follow-up (2 months) .

    Heart rate measurements taken throughout the day by a wearable device (wristband).

  2. Sleep-wake time

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Sleep-wake time (minutes) will be estimated based on measurements of movement and heart rate obtained from a wearable device (wristband)

  3. Sleep-Wake Time self-reported evaluation

    Time frame: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    The sleep-wake time (minutes) self-reported evaluation will be carried out using a predefined sleep diary which will be completed by the participant on the morning after he/she wakes up. Each assessment of sleep-wake time self-reported evaluation will be carried out for a whole week.

  4. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties.

  5. Hamilton Anxiety Rating Scale

    Time frame: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    The Hamilton Anxiety Rating Scale will be carried out to assess the severity of a person's anxiety. The Hamilton Anxiety Rating Scale ranges from 0 to 56, where higher scores indicate greater anxiety severity. The scoring is divided into severity tiers: <17 (mild), 18-24 (mild to moderate), and 25-56 (moderate to severe). The scale consists of 14 items, each rated from 0 to 4 points. It evaluates both psychic anxiety (e.g., tension, fears, mood) and somatic anxiety (physical complaints).

  6. Systolic/Diastolic Blood Pressure

    Time frame: Systolic/Diastolic blood pressure will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Measurements of Systolic/Diastolic Blood Pressure will be recorded.

  7. Heart Rate

    Time frame: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Heart rate will be measured using ECG.

  8. Heart Rate Variability

    Time frame: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Heart rate variability will be measured using ECG.

  9. Serum C-reactive Protein Levels

    Time frame: Serum levels of C-reactive protein will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum levels of C-reactive protein (mg/L), as a marker of systemic inflammation, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  10. Serum Urea Levels

    Time frame: Serum levels of urea will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum levels of urea (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  11. Serum Creatinine Levels

    Time frame: Serum levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  12. Serum Sodium levels

    Time frame: Serum levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  13. Serum Potassium Levels

    Time frame: Serum levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  14. Serum Osmolality

    Time frame: Serum osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Serum osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  15. Urine Creatinine Levels

    Time frame: Urine levels of creatinine will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Urine levels of creatinine (mg/dL), as a marker of renal function, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  16. Urine Sodium levels

    Time frame: Urine levels of sodium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Urine levels of sodium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  17. Urine Potassium levels

    Time frame: Urine levels of potassium will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Urine levels of potassium (mmol/L), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  18. Urine Osmolality

    Time frame: Urine osmolality will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Urine osmolality (mOsm/kg), as a marker of hydration, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  19. Hair cortisol levels

    Time frame: Hair cortisol levels will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Hair cortisol levels (pg/mg), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  20. Saliva alpha-amylase levels

    Time frame: Saliva levels of alpha-amylase will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).

    Saliva levels of alpha-amylase (U/mL), as a marker of stress, will be measured from each participant at baseline, middle (after 1 month), and at end of observation period (after 2 months).

  21. Humidity

    Time frame: Daily measurements - for the whole duration of follow-up (2 months).

    Humidity will be measured using iButton.

  22. The personal ambient temperature profile of all participants

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Personal exposures of participants will be monitored continuously during the two observation months with wearable sensors to be always worn and assess personal exposure to ambient (indoor and outdoor) temperature (iButton).

  23. Wet-bulb globe temperature (WGBT)

    Time frame: Daily measurements - for the whole duration of follow-up (2 months).

    Wet-bulb globe temperature, will be assessed as a thermal stress indicator.

  24. Indoor concentration levels of Particulate Matter 2.5 (PM 2.5) at residence

    Time frame: Daily measurements - for the whole duration of follow-up (2 months).

    Indoor concentration levels of PM2.5 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).

  25. Indoor concentration levels of Particulate Matter 10 (PM 10) at residence

    Time frame: Daily measurements - for the whole duration of follow-up (2 months).

    Indoor concentration levels of PM10 (micrograms per cubic meter of air) at participants' residences will be measured continuously indoors using commercial lightweight sensors (Alpha sense).

  26. Number of daily steps

    Time frame: Daily measurements - for the whole duration of follow-up (2 months)

    Number of daily steps will be measured throughout the day by a wearable device (wristband).

Study contacts

Contact information is provided by the study sponsor or research team.

Panayiotis Kouis, PhD

CONTACT

[email protected]

+35722895243

Panayiotis Yiallouros, Professor

CONTACT

[email protected]

+35722895212

Sponsors and collaborators

Lead sponsor

University of Cyprus

Other

Collaborators

  • University of Leon
  • University of Thessaly

Registry information

Official study title

Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks in Outdoor Workers

Acronym: ISMED-CLIM OW

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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